Long-Term Outcomes of Children With Congenital CMV in New York State

Last updated: May 12, 2025
Sponsor: Stony Brook University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cytomegalovirus Infections

Hearing Loss

Hearing Impairment

Treatment

N/A

Clinical Study ID

NCT06226558
75N94021D00018-75N94023F00001
  • Ages < 1
  • All Genders

Study Summary

PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms.

In particular, our study will provide new information about many facets of congenital CMV, including:

  • Developmental, hearing, neurologic, and vision outcomes

  • The spectrum and timing of symptoms

  • The impact congenital CMV has on the baby and its family

  • How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV

Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.

Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.

Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 -October 1, 2024)

  • cCMV evaluation provided by a designated NYS cCMV clinical referral site

  • Family willing and able to complete all study procedures

  • Study participants meet criteria for one of the following four categories:

  1. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screenpositive AND cCMV confirmatory test positive
  1. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newbornscreen negative AND cCMV confirmatory test positive
  1. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive ANDnegative cCMV confirmatory test
  1. Category 4 (Premature infants with confirmed CMV infection on late positiveNBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYSnewborn screen collected prior to 44 weeks gestational age AND Positive cCMVconfirmatory test obtained within 14 days of a positive NBS

Exclusion

Exclusion Criteria:

  • Neonate whose parents refuse participation in the long-term follow-up study

Study Design

Total Participants: 1000
Study Start date:
February 01, 2024
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • Stony Brook Children's Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

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